MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT; CATHETER EMBOLECTOMY

Catalog Number PT-65709-WC

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Complaint description: md was performing the procedure according to ifu.The catheter tip (rubber) was removed during the procedure.Md had to use new kit.The procedure was finished safely with the new product.

Event Description

Complaint description: md was performing the procedure according to ifu.The catheter tip (rubber) was removed during the procedure.Md had to use new kit.The procedure was fisnished safely with the new product.

Manufacturer Narrative

(b)(4).Additional information received from the customer states "there was a tip in the blood vessel with clot, so only a small incision was needed".The customer returned a lidstock, ptd rotator and orange lumen for investigation.The customer did not return the ptd catheter, basket or tip.The orange lumen was observed to have twisting and stress marks, which is caused when the ptd encounters resistance while being rotated.The orange lumen measured 1.880" which is within specification on 1.860-1.890" per basket lumen product drawing.Functional testing was performed by pressing the black on/off power button on the ptd rotator.Ptd turned on/off normally.A device history review was completed with no relevant findings.The current instructions-for-use (ifu) provided with this product provides guidance on the use of this product and warns the user to ensure the exposed portion of the catheter remains straight at all times to aid in successful basket deployment and that the catheter assembly is not to be advanced forward during activation.It also states that potential fatigue failure of the torque cable and fragmentation basket may occur with prolonged activation and recommends a limited activation time of 30-60 seconds.It warns that the rotating basket is to be withdrawn in the deployed position prior to reaching the sheath at a recommended rate of 1-2cm/second when sharp radii is encountered and that the catheter is not to be advanced forward during activation.The customer report of a damaged ptd tip/lumen was confirmed based on visual investigation of the received sample.The orange lumen was twisted and showed signs of stress.This damage is consistent with what occurs when the ptd encounters resistance while being rotated.Based on the condition of the returned sample and the evidence of use, it was determined that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT
• Type of Device: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8252987
• MDR Text Key: 133227107
• Report Number: 9680794-2019-00024
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K011056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: PT-65709-WC
• Device Lot Number: 13F18B0429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1